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  药店国别: 加拿大药房
产地国家: 加拿大
所属类别: 神经系统药物->治疗痛风药物
处方药:处方药
包装规格: 80毫克/片 30片/瓶
计价单位:
  点击放大  
生产厂家中文参考译名:
武田制药
生产厂家英文名:
Takeda Pharmaceuticals
该药品相关信息网址1:
http://www.uloric.com/
该药品相关信息网址2:
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.DrugDetails
原产地英文商品名:
ULORIC 80mg 30tab
原产地英文药品名:
FEBUXOSTAT
原产地英文化合物名称:
FEBUXOSTAT
中文参考商品译名:
优络瑞克 80毫克/片 30片/瓶
中文参考药品译名:
非布索坦
原产地国家批准上市年份:
0000/00/00
英文适应病症1:
gout
英文适应病症2:
Primary or secondary gout
英文适应病症3:
Gouty arthritis
英文适应病症4:
Complications caused by gout
临床试验期:
完成
中文适应病症参考翻译1:
痛风
中文适应病症参考翻译2:
原发性或继发性痛风
中文适应病症参考翻译3:
痛风性关节炎
中文适应病症参考翻译4:
痛风引起的并发症
药品信息:

药品信息

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友情提示:February 13 2009. The U.S. FDA has approved Adenuric (febuxostat). Its brand name in the U.S.is Uloric.
( Adenuric 在美国就是Uloric) 在欧洲共同体国家(EU) 用的名称是Adenuric (Febuxostat)
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申明:

世界药房销售之全部药品均为其药品原生产国政府药监部门(例如美国FDA)正式批准的合法药品。目前,世界药房自美国本土寄出,面向广大中国病患进行邮售服务的Uloric,为其原生产厂家Takeda Pharmaceuticals America, Inc.生产,并经美国药品销售体系流通的美国本土原装药品。

本药为美国FDA于2009年2月13日刚刚批准的新药,中国尚未批准进口,但近来国内某些网站和单位却以武田制药北美公司及药名Uloric的名义销售其自行配制的不同于Uloric的药物,希望广大病患予以警惕。根据美国FDA批准的剂量和用量,Uloric只有每片40毫克与每片80毫克的两个剂型;建议用量为起始40毫克剂量,一天一片;服用两星期后,如果sUA指标达不到<6mg/dL,建议服用80毫克剂量,一天一片。(ULORIC is recommended at 40 mg or 80 mg once daily. The recommended starting dose of ULORIC is 40 mg once daily. For patients who do not achieve a serum uric acid (sUA) less than 6 mg per dL after 2 weeks with 40 mg, ULORIC 80 mg is recommended.

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详细处方信息以本药内容附件PDF文件(200942303082929.pdf)的“原文Priscribing Information”为准
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美国FDA批准了近40年来的首个个用于治疗痛风药物FEBUXOSTAT(商品名ULORIC)

2009年2月16日,美国FDA批准了近40年来的第1个用于治疗高尿酸症的痛风药物。其为武田制药北美公司 (Takeda Pharmaceuticals North America)的非布索坦(febuxostat,ULORIC)。本品通过降低患者血液中的尿酸水平改善痛风患者的症状。此外,武田制药北美公司作为 本品在美国市场中的独立开发商与销售商。

根据武田公司的一项声明:本品的结构与40年前开发的黄嘌呤氧化酶抑制剂药物完全不同,它是一种全新的高效的非嘌呤类黄嘌呤氧化酶选择性抑制剂。黄嘌呤氧 化酶是促进尿酸生成的关键酶。本品可以降低高尿酸血症痛风患者血液中的尿酸水平,在临床研究中已经证明了本品的安全性和有效性,而且在中-重度肝肾功能不 全的患者中也不需要进行剂量调整。

本品的服用剂量为每日1次,一次40 毫克或者80毫克,但是本品不推荐用于无高尿酸血症的痛风患者。

本品的原研厂家为日本的另一家公司--日本帝人制药(Teijin Pharma)。在帝人制药公司总裁最近的一份声明中,我们可以了解公司对本品采取的全球战略。他称,在本品获得FDA的许可之前,Ipsen公司的产品 也获得了欧盟的上市许可。Ipsen 公司是帝人制药关于本品在欧盟的许可公司,而武田北美制药是本品在美国的许可公司。所以公司在全球已经取得的了里程碑式的战略意义。同时他还指出,在亚洲 市场,帝人制药将采取自主开发或联合开发的形式。

痛风是一组异质性疾病,遗传性和(或)获得性引起的尿酸排泄减少和(或)嘌呤代谢障碍。临床特点:高尿酸血症,以及尿酸盐结晶,沉积所致的特征性急性关节 炎、痛风石、间质性肾炎、严重者呈关节畸形及功能脏爱。常伴尿酸性尿路结石。假性痛风常常与痛风混淆,因为其症状非常的相似,然后,假性痛风是由于磷酸钙 的代谢障碍引起,而不是尿酸代谢障碍引起。

根据美国国家关节肌肉骨骼疾病与皮肤病研究所(NIAMS)的研究数据表明,在美国有600万20岁及其以上的人群生平中有患痛风的经历。通常40-50 岁的男性患者较为常见,而绝经前的女性患者少见。经历过器官移植的患者也容易患痛风。NIAMS指出下列药物会增加患痛风的风险(1)利尿剂:呋塞米(furosemide);氢氯噻嗪(hydrochlorothiazide);美托拉宗(metolazone)(2)水杨酸类:如阿司匹林 (aspirin)(3)烟酸(4)环孢菌素 (Cyclosporine Neoral),(5)左旋多巴 (Levodopa)。

Important Safety and Other Information

ULORIC is a prescription medicine used to lower blood uric acid levels in adults with gout. Individual results may vary.

Do not take ULORIC if you are taking Azathioprine (Imuran®, Azasan®), Mercaptopurine (Purinethol®), or Theophylline (Theo-24®, Elixophyllin®, Theochron®, Theolair®, Uniphyl®).

For some people, gout may flare up when starting certain gout medicines, including ULORIC. If you have a flare while taking ULORIC, do not stop taking your medicine. Your healthcare provider may give you other medicines to help prevent your gout flares.

Heart Problems. A small number of heart attacks, strokes and heart-related deaths were seen in clinical studies. It is not certain that ULORIC caused these events.

Your healthcare professional may do blood tests to check your liver function while you are taking ULORIC.

The most common side effects are liver problems, nausea, gout flares, joint pain, and rash.

Uloric - What You Need to Know
Uloric, generic name febuxostat, has been approved by the FDA for the chronic management of hyperuricemia in gout. Uloric is the first new treatment option for gout in over 40 years.

Uloric Recommended for FDA Approval
The FDA arthritis advisory committee has recommended the approval of Uloric for the treatment of gout. Uloric, the name that has been given to generic Febuxostat, was recommended by a 12-0 vote (one member of the committee abstained).

Febuxostat: More Effective Than Standard Drug
Febuxostat, a new treatment for gout, is at least twice as effective at lowering uric acid levels than allopurinol. Study results about febuxostat came from the largest and longest trial of gout drugs ever conducted.

Mismanagement of Gouty Arthritis Not Uncommon
Although gouty arthritis is not considered a difficult disease to diagnose and gout treatments are very effective in most cases, errors in the management of gout are common.

Gout - 10 Things You Should Know
Gout is an intensely painful type of arthritis. There are 10 important facts you should know about gout.

Fast Facts About Gout
Gout is one of the most painful types of arthritis. Gout is caused by uric acid crystals deposited in the body's tissues which lead to recurrent attacks of joint inflammation.

Gout Screening Quiz
Gout is one of the most painful types of arthritis. Do you have symptoms which are associated with gout? Do you have a lifestyle which increases the risk factors associated with gout? Take our Gout Screening Quiz.

Gout Risk Factor Quiz
A risk factor increases your chances of developing gout but it is not certain that you will develop the disease. What factors increase the risk of developing gout?

How to Recognize the Signs and Symptoms of Gout
Gout symptoms are very painful and are caused by monosodium urate crystals in joints and surrounding tissues. Gout symptoms can occur with more frequency if untreated.

The Gout Quiz - Test Your Knowledge of Gout
How much do you know about gout? You probably heard of it, but do you know the difference between purines and gout medication probenecid? Do you know what you need to do to prevent gout attacks? Does your lifestyle put you at risk for gout? Take the Gout Quiz and test your knowledge.

How To Treat Gout With Diet And Medication
Gout is one of the most painful types of arthritis. Gout attacks can be controlled or prevented by lifestyle changes and the use of certain medications.

The Gout Guide: Free E-Course Newsletter
We have designed our free newsletter e-course to guide you to better understand gout. Learn more about gout basics, gout history, gout cause, gout diagnosis, gout treatment, gout prevention, gout diet, gout medication, and gout research.

New Gout Drug Gets FDA Panel Nod

Uloric, First New Gout Drug in 40 Years, Recommended for FDA Approval

By Daniel J. DeNoon
WebMD Health NewsReviewed by Louise Chang, MDNov. 24, 2008 -- Uloric should be the first new gout drug to be approved in over 40 years, an FDA expert panel recommends.

Currently, allopurinol (trade name, Zyloprim) is the only FDA-approved drug that prevents formation of the uric acid crystals that cause gout. However, side effects -- including potentially fatal reactions -- limit the amount of allopurinol that can be tolerated. Most gout patients do not receive fully effective doses of allopurinol.

In clinical trials sponsored by Takeda, Uloric's manufacturer, an 80-milligram dose of Uloric worked better than allopurinol; a 40-milligram dose worked at least as well as allopurinol.

Unlike allopurinol, very little Uloric is excreted through the urine, making Uloric safe for patients with kidney problems. Gout patients with impaired kidney function have to take very low doses of allopurinol, making the drug even less effective for these patients.

In 2005, the FDA refused to approve Uloric because there were slightly more deaths and heart problems in patients taking the drug than in patients taking allopurinol. As people with gout problems already are at higher risk of heart disease, the FDA issued an "approvable" letter, noting that Uloric could be approved if this safety question were addressed.

Takeda then performed a large new phase 3 clinical trial that enrolled more gout patients than the two previous phase 3 trials combined. The new study found no more deaths and no more heart problems in patients taking Uloric than in patients taking allopurinol.

Based on the safety and efficacy data, the FDA panel recommended by a 12-0 vote that the FDA approve Uloric at both the 40-milligram and 80-milligram doses. Takeda suggests the higher dose is more effective in subjects with more severe gout.

Takeda has offered to continue studying Uloric after FDA approval. A phase 4 clinical trial would compare Uloric to allopurinol for the reduction of gout flare-ups.

And because drugs with the same mechanism of action as Uloric and allopurinol may affect theophylline bronchodilators, Takeda has agreed to conduct a postmarketing phase 1 study of Uloric's interactions with theophylline.

Gout occurs when blood levels of uric acid rise. At blood levels above 7 mg/dL -- and above 6 mg/dL in the extremities -- crystals can form that lodge in the joints and other body tissues. These crystal deposits provoke an immune response that results in extremely painful swelling and in inflammatory arthritis that can permanently destroy the joints.

(For more on the causes, symptoms, and treatment of gout, see WebMD's Gout Pictures Slideshow.)

About 1.4% of men and 0.6% of women have gout. But prevalence rises with age. After age 80, about 9% of men and 6% of women develop gout.

The body converts a chemical called xanthine into uric acid via an enzyme called xanthine oxidase or XO. Allopurinol and Uloric each inhibit XO and prevent the formation of uric acid.

Allopurinol is approved in doses up to 800 milligrams. However, it's rarely dosed above 300 milligrams per day and is often ineffective. Allopurinol side effects include upset stomach, headache, diarrhea, and rash. Although rare, allopurinol hypersensitivity syndrome can develop. It's fatal 20% to 30% of the time.

The most common side effects seen in patients taking Uloric during clinical trials were upper respiratory tract infections, muscle and connective-tissue symptoms, and diarrhea. The drug was well tolerated, and these side effects did not increase over long-term use.

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详细处方信息以本药内容附件PDF文件(200942303082929.pdf)的“原文Priscribing Information”为准

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